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Item Addressing Gaps in Pediatric Scientist Development: The Department Chair View of Two AMSPDC-Sponsored Programs(Elsevier, 2020) Barrett, Katherine J.; Cooley, Michelle; Schwartz, Alan L.; Hostetter, Margaret K.; Clapp, D. Wade; Permar, Sallie R.; Pediatrics, School of MedicinePediatric physician-scientists are important members of the biomedical workforce who are instrumental in translating research advances into novel patient treatment strategies, yet their numbers have been declining over the past four decades. In order to increase the pipeline of pediatric physician-scientists, the Association of Medical School Pediatric Department Chairs (AMSPDC) leads the Frontiers in Science (FIS) and Pediatric Scientist Development Program (PSDP). These programs provide mentorship, networking, and funding opportunities for pediatric residents and fellows who are interested in pursuing research careers. To assess perceptions of program accessibility and efficacy, FIS and PSDP leadership surveyed AMSPDC membership between November 2018 and April 2019; 66 active department chairs responded. The decline in pediatric physician-scientists was identified as a common concern, and responding chairs identified several individual and institutional barriers to the physician-scientist career pathway and to participation in FIS and PSDP. Common barriers to participation included: undefined career paths for physician-scientists, a limited number of FIS slots annually, a perception that these programs support primarily basic science rather than other types of research, and competing funding through institutional T32 and K12 programs. To address these barriers, FIS and PSDP leadership will work with AMSPDC to explore ways to increase access to FIS, promote PSDP alumni mentoring of participating residents and fellows, and expand the scope of research supported by these programs. Assessments of FIS and PSDP will be ongoing, with the goal of improving program access in order to increase and diversify the pediatric physician-scientist workforce.Item Development of a Research Agenda for the Management of Metastatic Colorectal Cancer: Proceedings from a Multidisciplinary Research Consensus Panel(Elsevier, 2012-02) d’Othée, Bertrand Janne; Sofocleous, Constantinos T.; Hanna, Nader; Lewandowski, Robert J.; Soulen, Michael C.; Vauthey, Jean-Nicolas; Cohen, Steven J.; Venook, Alan P.; Johnson, Matthew S.; Kennedy, Andrew S.; Murthy, Ravi; Geschwind, Jean-Francois; Kee, Stephen T.; Department of Radiology and Imaging Sciences, IU School of MedicineItem Editorial: The vulnerable physician-scientist(The Endocrine Society, 2014-05) Mirmira, Raghavendra G.; Department of Pediatrics, IU School of MedicineItem The impact of COVID-19 pandemic on vascular registries and clinical trials(Elsevier, 2021-06) Aziz, Faisal; Behrendt, Christian-Alexander; Sullivan, Kaity; Beck, Adam W.; Beiles, C. Barry; Boyle, Jon R.; Mani, Kevin; Benson, Ruth A.; Wohlauer, Max V.; Khashram, Manar; Jorgensen, Jens Eldrup; Lemmon, Gary W.; Surgery, School of MedicineQuality improvement programs and clinical trial research experienced disruption due to the coronavirus disease 2019 (COVID-19) pandemic. Vascular registries showed an immediate impact with significant declines in second-quarter vascular procedure volumes witnessed across Europe and the United States. To better understand the magnitude and impact of the pandemic, organizations and study groups sent grass roots surveys to vascular specialists for needs assessment. Several vascular registries responded quickly by insertion of COVID-19 variables into their data collection forms. More than 80% of clinical trials have been reported delayed or not started due to factors that included loss of enrollment from patient concerns or mandated institutional shutdowns, weighing the risk of trial participation on patient safety. Preliminary data of patients undergoing vascular surgery with active COVID-19 infection show inferior outcomes (morbidity) and increased mortality. Disease-specific vascular surgery study collaboratives about COVID-19 were created for the desire to study the disease in a more focused manner than possible through registry outcomes. This review describes the pandemic effect on multiple VASCUNET registries including Germany (GermanVasc), Sweden (SwedVasc), United Kingdom (UK National Vascular Registry), Australia and New Zealand (bi-national Australasian Vascular Audit), as well as the United States (Society for Vascular Surgery Vascular Quality Initiative). We will highlight the continued collaboration of VASCUNET with the Vascular Quality Initiative in the International Consortium of Vascular Registries as part of the Medical Device Epidemiology Network coordinated registry network. Vascular registries must remain flexible and responsive to new and future real-world problems affecting vascular patients.Item In praise of scientific review officers(Oxford University Press, 2014-07) Elahi, Dariush; Mirmira, Raghavendra G.; Kushner, Jake A.; Cellular and Integrative Physiology, School of MedicineItem International Research Ethics: A Needs Assessment of Research Ethics Capacity Final Report and Responses(2006-09-11T13:32:14Z) Meslin, Eric M.; Sidle, JE; Wools-Kaloustian, K; Were, E; Salmon, K; Chuani, CInternational collaborative research often raises challenging ethical issues for researchers, review committees and institutions. To date, much of the commentary and discussion surrounding these issues have focused on difficulties in interpreting guidelines, regulations, and policies and on the lack of harmonization. Efforts at regulatory reform and guideline development is one method of contributing to research ethics capacity building, but these are “top-down” approaches involving governments, regulatory agencies, and the challenge of achieving consensus. A complementary strategy is to work from the “ground up”: fashioning collaborative agreements between institutions, ethics review committees, and researchers. Working from the “ground up,” we conducted a needs assessment with participants from the Indiana University School of Medicine and the Moi University Faculty of Health Science in order to determine how best to implement a Memorandum of Understanding (MOU) developed between the two institutions. The MOU was designed to address the working relationship between the two universities with respect to their joint research activities and was the product of a Workshop convened in Eldoret, Kenya in February 2003. This work is a direct result of the MOU which explicitly states that “It is expected and intended that among the actions arising from this MOU will be the development of policies, Standard Operating Procedures and other resources that will address specific issues not mentioned here.” The interviews and focus groups provided a wealth of information about current knowledge, policies, procedures, and systems in place at MU and IU, respectively. They also provided a rich source of ideas for enhancing research ethics capacity.Item A Needs Assessment to Build International Research Ethics Capacity at Moi University(University of California Press Caliber (Online service), 2006-06) Sidle, JE; Were, E; Wools-Kaloustian, K; Chuani, C; Salmon, K; Tierney, WM; Meslin, Eric M.International collaborators in biomedical sciences face ethical challenges in the design,review, and conduct of research. Challenges include differences in research ethics capacity, cultural differences in interpretation and application of ethical principles, and cooperation between ethics review boards at collaborating institutions. Indiana University School of Medicine (Indianapolis, USA) and Moi University Faculty of Health Sciences (Eldoret, Kenya)developed a Memorandum of Understanding (MOU) to establish greater cooperation between their ethics review boards, followed by a joint needs assessment to assess barriers to implementing the MOU. Focus groups and interviews at each institution revealed that while each side verbalized understanding and respect for the other's culture, there were misunderstandings deeply rooted in each culture that could potentially derail the collaboration. Although the participants at each university agreed on the major principles and issues in research ethics and on the importance attributed to them, a more in-depth evaluation of the responses revealed important differences. Methods to address these misunderstandings are outlined in the recommended Best Practices.Item Public Attitudes Regarding Genetic Research: Summary of Methods and Findings(2009-10-09T21:31:24Z) Survey Research Center at IUPUI; Wolf, James G.The Indiana University School of Medicine Center for Bioethics Program in Predictive Health Ethics Research commissioned the Survey Research Center at IUPUI to conduct a random-digit-dial telephone survey of Indiana residents in an effort to determine the following: the public’s perception of its own understanding of medical and genetic research, public confidence in medical and genetic research, the likelihood of participation if asked, and the sense of public control of genetic research. The following report details the main findings from this research.Item Report and recommendations: Research involving prisoners -- Part I(1976) United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchPart I of this report contains the recommendations as well as the deliberations and conclusions of the Commission and a summary of background materials.Item RESEARCH ETHICS. Ethics review for international data-intensive research(American Association for the Advancement of Science, 2016-03-25) Dove, Edward S.; Townend, David; Meslin, Eric M.; Bobrow, Martin; Littler, Katherine; Nicol, Dianne; de Vries, Jantina; Junker, Anne; Garattini, Chiara; Bovenberg, Jasper; Shabani, Mahsa; Lévesque, Emmanuelle; Knoppers, Bartha M.; Indiana University Center for Bioethics, IU School of Medicine